RT Journal Article
T1 Long-term efficacy and tolerability of flutamide combined with oral contraception in moderate to severe hirsutism: A 12-month, double-blind, parallel clinical trial
A1 Calaf, J
A1 López, E
A1 Millet, A
A1 Alcañiz, J
A1 Fortuny, A
A1 Vidal, O
A1 Callejo, J
A1 Escobar-Jiménez, F
A1 Torres, E
A1 Espinós, J J
K1 Acné Vulgar
K1 Adolescente
K1 Adulto
K1 Antagonistas de Andrógenos
K1 Anticonceptivos Hormonales Orales
K1 Dermatitis Seborreica
K1 Relación Dosis-Respuesta a Droga
K1 Método Doble Ciego
K1 Esquema de Medicación
K1 Quimioterapia Combinada
K1 Femenino
K1 Flutamida
K1 Hirsutismo
K1 Humanos
K1 Placebos
K1 Factores de Tiempo
K1 Resultado del Tratamiento
AB OBJECTIVEOur objective was to test the efficacy and tolerability of three doses of flutamide (125, 250, and 375 mg) combined with a triphasic oral contraceptive (ethynylestradiol/levonorgestrel) during 12 months to treat moderate to severe hirsutism in patients with polycystic ovary syndrome or idiopathic hirsutism.DESIGNWe conducted a randomized, double-blind, placebo-controlled, parallel clinical trial.PATIENTSA total of 131 premenopausal women, suffering from moderate to severe hirsutism, were randomized to placebo or 125, 250, or 375 mg flutamide daily associated with a triphasic oral contraceptive pill. Hirsutism (Ferriman-Gallwey), acne and seborrhea (Cremoncini), and hormone serum levels were monitored at baseline and at 3 (except hormone serum levels), 6, and 12 months. Side effects and biochemical, hematological, and hepatic parameters were assessed.METHODSWe used three-way ANOVA (subject, dose, and visit) with Scheffé adjustment for multiple comparisons or nonparametrical Friedman test and least-squares mean (paired data) and Kruskall-Wallis test for unpaired data analyses. We used chi(2) or Fisher's test for categorical data.RESULTSA total of 119 patients were included in the intention-to-treat analysis. All flutamide doses induced a significant decrease in hirsutism, acne, and seborrhea scores after 12 months compared with placebo without differences among dose levels. Similar related side effects were observed with placebo and 125 mg flutamide (12.5%), and slightly higher with 250 mg (17.3%) and 375 mg (21.2%). No statistically significant differences were observed either among doses or compared with placebo.CONCLUSIONSFlutamide at 125 mg daily during 12 months was the minimum effective dose to diminish hirsutism in patients with polycystic ovary syndrome or with idiopathic hirsutism.
PB The Endocrine Society
YR 2007
FD 2007-09
LK http://hdl.handle.net/10668/684
UL http://hdl.handle.net/10668/684
LA en
NO Calaf J, López E, Millet A, Alcañiz J, Fortuny A, Vidal O, et al. Long-term efficacy and tolerability of flutamide combined with oral contraception in moderate to severe hirsutism: a 12-month, double-blind, parallel clinical trial. J. Clin. Endocrinol. Metab.. 2007 Sep; 92(9):3446-52
NO Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
DS RISalud
RD Apr 9, 2025